SchizophreniaPhase 3NCT00396214
Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
A Phase 3 study testing Bifeprunox and Quetiapine in people with Schizophrenia, run by Solvay Pharmaceuticals at 151 sites in 14 countries.
Trial summary
The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Bifeprunox and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 151 sitesin 14 countries
- Study dates
- Apr 2007to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Schizophrenia
- 18-65 years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
Who cannot join
- Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
- At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
Trial locations and contacts
151 sites in 14 countries.
151 sites in 14 countries
United States69 sites
Site 313
Anaheim, California
Site 333
Anaheim, California
Site 330
Atlanta, Georgia
Site 308
Augusta, Georgia
Site 307
Austin, Texas
Site 310
Buffalo, New York
Site 312
Buffalo, New York
Site 306
Cedarhurst, New York
Site 323
Cerritos, California
Site 337
Chicago, Illinois
Site 329
Cincinnati, Ohio
Site 320
Clementon, New Jersey
Site 347
Clementon, New Jersey
Site 303
Conroe, Texas
Site 374
Costa Mesa, California
Site 326
Culver City, California
Site 371
Darien, Connecticut
Site 370
Decatur, Georgia
Site 318
Denver, Colorado
Site 328
Detroit, Michigan
Site 301
Glen Burnie, Maryland
Site 300
Glendale, California
Site 358
Hartford, Connecticut
Site 317
Hialeah, Florida
Site 305
Houston, Texas
Site 335
Indianapolis, Indiana
Site 341
Lake Charles, Louisiana
Site 362
Largo, Florida
Site 343
Long Beach, California
Site 356
Los Angeles, California
Site 367
Los Angeles, California
Site 352
Memphis, Tennessee
Site 327
Miami, Florida
Site 373
Miami, Florida
Site 357
Minneapolis, Minnesota
Site 360
New Britain, Connecticut
Site 321
New York, New York
Site 353
New York, New York
Site 372
New York, New York
Site 334
North Miami, Florida
Site 351
North Miami, Florida
Site 361
Oakbrook Terrace, Illinois
Site 322
Oceanside, California
Site 345
Oklahoma City, Oklahoma
Site 368
Oklahoma City, Oklahoma
Site 369
Omaha, Nebraska
Site 338
Orange City, Florida
Site 316
Pasadena, California
Site 314
Philadelphia, Pennsylvania
Site 346
Philadelphia, Pennsylvania
Site 348
Philadelphia, Pennsylvania
Site 354
Portland, Oregon
Site 319
Richmond, Virginia
Site 302
Sacramento, California
Site 325
San Antonio, Texas
Site 315
San Diego, California
Site 331
San Diego, California
Site 340
San Diego, California
Site 311
Santa Ana, California
Site 336
Santa Ana, California
Site 304
Shreveport, Louisiana
Site 350
Sioux Falls, South Dakota
Site 366
Smyma, Georgia
Site 349
Spokane, Washington
Site 309
St Louis, Missouri
Site 324
Staten Island, New York
Site 332
Tampa, Florida
Site 344
Torrance, California
Site 342
Towson, Maryland
Canada12 sites
Site 400
Burlington, Ontario
Site 401
Chatham, Ontario
Site 408
Halifax, Nova Scotia
Site 409
Hull, Quebec
Site 406
Kelowna, British Columbia
Site 404
Mississauga, Ontario
Site 407
Orléans, Ontario
Site 405
Ottawa, Ontario
Site 403
Prince Albert, Saskatchewan
Site 410
Saskatoon, Saskatchewan
Site 413
Sydney
Site 411
Victoria, British Columbia
Argentina10 sites
Site 502
Buenos Aires
Site 506
Buenos Aires
Site 505
Córdoba
Site 507
Córdoba
Site 508
La Plata
Site 355
Little Rock
Site 501
Mendoza
Site 504
Mendoza
Site 509
Mendoza
Site 503
Rosario
Chile10 sites
Site 514
Coquimbo
Site 510
Santiago
Site 511
Santiago
Site 512
Santiago
Site 513
Santiago
Site 516
Santiago
Site 517
Santiago
Site 518
Santiago
Site 519
Santiago
Site 515
Valdivia
Germany8 sites
Site 612
Berlin
Site 613
Berlin
Site 617
Berlin
Site 620
Berlin
Site 619
Bochum-Gerthe
Site 616
Bonn
Site 615
München
Site 618
Siegen
South Africa8 sites
Site 707
Aucklandpark
Site 703
Bellair
Site 700
Cape Town
Site 705
Cape Town
Site 706
Cape Town
Site 702
Johannesburg
Site 701
Pretoria
Site 704
Pretoria
Czechia7 sites
Site 636
České Budějovice
Site 637
Kutná Hora
Site 604
Litoměřice
Site 600
Olomouc
Site 601
Pilsen
Site 602
Prague
Site 605
Prague
Peru6 sites
Site 520
Lima
Site 521
Lima
Site 522
Lima
Site 523
Lima
Site 524
Lima
Site 525
Lima
Hungary5 sites
Site 621
Balassagyarmat
Site 623
Budapest
Site 624
Győr
Site 625
Gyula
Site 622
Pécs
Slovakia5 sites
Site 631
Bojnice
Site 634
Bratislava
Site 632
Liptovský Mikuláš
Site 635
Michalovce
Site 633
Rimavská Sobota
About this study
Official title: A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.
- Conditions
- Schizophrenia
- Being tested
- Bifeprunox, Quetiapine
- Keywords
- Schizophrenia, weight changes
- Medical subject headings
- Schizophrenia, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifeprunoxDrug
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
QuetiapineDrug
Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
BifeprunoxDrug
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Bifeprunox |
| 2 | Experimental | Not described Receives: Drug: Bifeprunox |
| 3 | Active comparator | Not described Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 8 weeks
Secondary outcomes (3)
Change from baseline in Triglyceride
Measured: 8 weeks
Detorioration (composite definition using PANSS total score and CGI-I)
Measured: 26 weeks
Change from baseline in Weight, Triglyceride and Cardiovascular risk factors
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: This trial discontinued on 2 May 2008 due to lack of enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396214
- Sponsor's protocol ID
- S154.3.021
- Other IDs
- 2006-004973-83
- Status last verified
- May 2008
- First submitted
- 3 Nov 2006
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00396214
- Acronym / sponsor ID
- S154.3.021
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, weight changes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This trial discontinued on 2 May 2008 due to lack of enrolment
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bifeprunox |
| 2 | Experimental | Drug: Bifeprunox |
| 3 | Active comparator | Drug: Quetiapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Schizophrenia
- 18-65 years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
Key exclusion criteria (2 listed)
- Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
- At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifeprunox52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose. | Drug | 1 |
| QuetiapineFixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day. | Drug | 3 |
| Bifeprunox52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose. | Drug | 2 |
Primary outcome
Weight
Time frame: 8 weeks
3 secondary outcomes
Change from baseline in Triglyceride
Time frame: 8 weeks
Detorioration (composite definition using PANSS total score and CGI-I)
Time frame: 26 weeks
Change from baseline in Weight, Triglyceride and Cardiovascular risk factors
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: This trial discontinued on 2 May 2008 due to lack of enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
151 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifeprunox and Quetiapine in people with Schizophrenia, run by Solvay Pharmaceuticals at 151 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 151 sites in United States, Canada, Argentina, Chile, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This trial discontinued on 2 May 2008 due to lack of enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.